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FDA NDA · NDA020189

FELBATOL

felbamate

Sponsor: MYLAN SPECIALITY LP

APPLICATION
NDA020189
TYPE
NDA
ORIGINAL APPROVAL
1993-07-29
LATEST ACTION
2012-08-31
ROUTE
ORAL
DOSAGE FORM
SUSPENSION, TABLET
MARKETING STATUS
Discontinued, Prescription

Products

FELBATOL · ReferenceDiscontinued
FELBAMATE 600MG/5ML · SUSPENSION · ORAL
FELBATOL · ReferencePrescription
FELBAMATE 400MG · TABLET · ORAL
FELBATOL · ReferencePrescription
FELBAMATE 600MG · TABLET · ORAL

Approval history

2012-08-31Labeling · Supplement 27 · standard — Medication Guide ↗AP
2011-07-06Labeling · Supplement 23 · standard — Letter ↗AP
2009-04-23Labeling · Supplement 22 · 901 required — Label ↗AP
2002-11-19Labeling · Supplement 18 · standard — Letter ↗AP
2002-06-26Manufacturing (CMC) · Supplement 19 · priorityAP
1995-08-28Manufacturing (CMC) · Supplement 12 · priorityAP
1995-06-26Manufacturing (CMC) · Supplement 11 · priorityAP
1995-01-24Manufacturing (CMC) · Supplement 10 · priorityAP
1994-11-29Labeling · Supplement 9 · standardAP
1994-11-01Labeling · Supplement 8 · standardAP
1994-11-01Labeling · Supplement 6 · standardAP
1994-05-31Manufacturing (CMC) · Supplement 5 · priorityAP
1994-03-02Labeling · Supplement 4 · standardAP
1993-12-21Manufacturing (CMC) · Supplement 3 · priorityAP
1993-12-20Manufacturing (CMC) · Supplement 2 · priorityAP
1993-09-17Manufacturing (CMC) · Supplement 1 · priorityAP
1993-07-29Type 1 - New Molecular Entity · Original · priority — Healthcare Professional Sheet ↗AP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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